On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free survival. Based on an interim analysis and following review by the Independent Data Monitoring Committee, post-resection adjuvant therapy with pembrolizumab resulted in significantly longer recurrence-free survival than placebo (hazard ratio [HR] = 0.57; 98.4% confidence interval [CI] = 0.43–0.74; P < .0001). The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported studies involving patients with advanced melanoma.

In accordance with the trial protocol, the study will continue in order to evaluate other key endpoints, including overall survival. Results from EORTC1325/KEYNOTE-054 will be presented at an upcoming medical meeting, and submitted to regulatory authorities.

“This has been a great collaboration between Merck and the EORTC, and the findings from this interim analysis show the potential for pembrolizumab to significantly prolong the time before the disease recurs in patients with high-risk melanoma,” said Roger Dansey, MD, Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories. “This result demonstrates the meaningful benefit that pembrolizumab offers for patients with melanoma.”

“This result shows a significant advancement for patients that could potentially change the way melanoma is treated in the future,” said Alexander Eggermont, MD, PhD, Study Chair; Director General at the Gustave Roussy Cancer Institute; and Professor of Oncology, University of Paris-Saclay.

In total, the study enrolled 1,019 patients who were randomly assigned to receive either pembrolizumab at a flat dose of 200 mg intravenously (IV) on day 1 of each 21-day cycle for up to 1 year or placebo IV on day 1 of each 21-day cycle for up to 1 year. This represents a total of 18 outpatient administrations.

The primary endpoint is recurrence-free survival for all patients and recurrence-free survival in patients whose tumors express programmed cell death ligand 1 (PD-L1); secondary endpoints include distant metastases-free survival and overall survival in all patients and in patients whose tumors express PD-L1.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.